Johnson & Johnson shared new phase 3 data and real-world evidence related to the effectiveness of the Janssen COVID-19 vaccine.

The real-world evidence study included 390,517 individuals 18 years of age and older who were newly vaccinated with the Janssen COVID-19 vaccine and 1,524,153 unvaccinated individuals matched by age, sex, date, location, comorbidity index, and 17 COVID-19 risk factors. 

Vaccine effectiveness was reported to be 79% (95% CI, 77-80) for COVID-19-related infections and 81% (95% CI, 79-84) for COVID-19-related hospitalizations. There was no evidence of reduced effectiveness throughout the study, including when the Delta variant became dominant in the United States.


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The findings were consistent with those observed in the phase 3 ENSEMBLE trial (ClinicalTrials.gov Identifier: NCT04505722), which showed 74% efficacy (95% CI, 39-91) in the US against severe/critical COVID-19, 89% efficacy (95% CI, 24-100) against hospitalization, and 83% efficacy (95% CI, 41-97) against COVID-19-related death.

The randomized, double-blind, placebo-controlled phase 3 ENSEMBLE 2 study (ClinicalTrials.gov Identifier: NCT04614948) evaluated the efficacy and safety of a booster dose of the Janssen COVID-19 vaccine in individuals 18 years of age and older. Participants received a booster dose 56 days after the first dose.

Findings showed that the booster dose provided 100% protection (95% CI, 33-100) against severe/critical COVID-19 at least 14 days post-final vaccination and 94% protection (95% CI, 58-100) against symptomatic (moderate to severe/critical) COVID-19 in the US.

When the booster dose was given at 2 months, antibody levels were observed to be 4 to 6 times higher than after the first shot. When the booster dose was administered 6 months after the first shot, a 12-fold increase in antibodies was observed after 4 weeks.

“We now have generated evidence that a booster shot further increases protection against COVID-19 and is expected to extend the duration of protection significantly,” said Paul Stoffels, MD, Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson.

The Janssen COVID-19 vaccine is currently authorized under the Food and Drug Administration’s Emergency Use Authorization for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. 

The Company has submitted the new data to the FDA for review.

Reference

Johnson & Johnson announces real-world evidence and phase 3 data confirming strong and long-lasting protection of single-shot COVID-19 vaccine in the US. News release. Johnson & Johnson. https://www.prnewswire.com/news-releases/johnson–johnson-announces-real-world-evidence-and-phase-3-data-confirming-strong-and-long-lasting-protection-of-single-shot-covid-19-vaccine-in-the-us-301381176.html

This article originally appeared on MPR